Mindful Self-Compassion (MSC) for Infertility Related Distress

NCT ID: NCT05183568

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-07-01

Brief Summary

This study will test a psychological intervention for the treatment of distress related to infertility. The intervention will pair reading a book "The Mindful Self-Compassion Workbook" by Kristin Neff with guided meditations using the Centre for Mindfulness Studies mobile app. Individuals with infertility will complete the 8-week program and complete psychological outcome measures before and after.

Detailed Description

The investigators will recruit 50 women struggling with infertility across Canada and the United States via a paid Facebook ad as well as advertising via online infertility support groups. Participants will undergo an 8-week self-help program consisting of assigned weekly chapters in the workbook entitled "The Mindful Self-Compassion Workbook: A Proven Way to Accept Yourself, Build Inner Strength, and Thrive" (Neff & Germer, 2018), paired with daily guided meditations provided through a free smartphone app that was developed by the Centre for Mindfulness Studies, a Canadian-based mental health charity. The app is free to download on the app store for iPhone and Android. After completing a Zoom-faciliated enrollment session during which eligibility will be confirmed and informed consent obtained, participants will be mailed a copy of the workbook and instructed to complete three chapters per week for a total eight weeks. Each chapter is approximately 5-7 pages long but includes reflection exercises that may take some time - each chapter is therefore expected to take participants approximately 20 minutes to read. Participants will be sent a weekly email to remind them of their assigned chapters to read each week by the graduate student researcher.

Before starting the program, participants will be asked to complete a demographics form and the Credibility/Expectancy Questionnaire (CEQ) pre-intervention, as well as a series of questionnaires both before and after the intervention. The questionnaires are as follows: Fertility Quality of life Questionnaire (FertQoL), State-Trait Anxiety Inventory (STAI), the Generalised Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), The Five Facet Mindfulness Questionnaire-15 (FFMQ-15), The Self-Compassion Scale, The Compassion Scale, the Revised Dyadic Adjustment Scale (RDAS) and a brief survey about what participants liked or disliked about the program. These surveys will be completed at baseline, at the end of the 8th intervention week, and then one month after the program is over. Participants' app usage will be tracked by the Centre for Mindfulness Studies and shared with our research team, allowing us to assess adherence to the assigned homework.

Conditions

Infertility, Female; Distress, Emotional; Depressive Symptoms; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindful Self-Compassion

Participants will undergo an 8-week self-help program consisting of assigned weekly chapters in the workbook entitled "The Mindful Self-Compassion Workbook: A Proven Way to Accept Yourself, Build Inner Strength, and Thrive" (Neff \& Germer, 2018), paired with daily guided meditations provided through a free smartphone app that was developed by the Centre for Mindfulness Studies, a Canadian-based mental health charity.

Group Type: EXPERIMENTAL

Mindful Self-Compassion

Intervention Type: BEHAVIORAL

Self-guided bibliotherapy (specific chapters to read each week) and daily use of a meditation app for 45 minutes

Interventions

Mindful Self-Compassion

Self-guided bibliotherapy (specific chapters to read each week) and daily use of a meditation app for 45 minutes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• Undergoing fertility treatments or who have failed to conceive despite a 12 month period without the use of contraception
• Reporting distress related to infertility, as indicated by Fertility Quality of Life Questionnaire score below 70, which is indicative of below-average quality of life

Exclusion Criteria

• Currently seeking psychological treatment
• Participation in a formal mindfulness program within 6 months of recruitment
• Endorsement of active suicidal ideation, indicated by a score of 8 or above on the Suicidal Behaviors Questionnaire
• GAD-7 score of 15-21, indicating severe generalized anxiety
• PHQ-9 score of 20-27, indicating severe depressive symptoms.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Gordon

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

Other Identifiers

REB #2021-133

Identifier Type: -

Identifier Source: org_study_id